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PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents

Primary Purpose

Peripheral Vascular Diseases, Intermittent Claudication, Angioplasty

Status

Completed

Phase

Phase 4

Locations

Austria

Study Type

Interventional

Intervention

Nitinol stent

Nitinol Stent Placement

About this trial

This is an interventional treatment trial for Peripheral Vascular Diseases focused on measuring peripheral vascular diseases, Intermittent Claudication, Angioplasty

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

symptomatic peripheral artery disease with severe intermittent claudication (Fontaine stage IIb)
critical limb ischemia in patients with stenosis or occlusions originating in the SFA
up to 25 cm length of stenosis/occlusion

Exclusion Criteria:

previous bypass surgery at the site of treatment
history of intolerance of anti-platelet therapy
adverse reaction to heparin
bleeding diathesis
creatinine >2.5 mg/dL
active bacterial infection
allergy to contrast media
previous stent placement at or immediately adjacent to the target lesion

Sites / Locations

University Hospital of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

primary nitinol stent placement of superficial femoral artery lesions

balloon angioplasty of superficial artery lesions with secondary stent placement in case of >30% residual stenosis after the procedure

Outcomes

Primary Outcome Measures

occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis).

Secondary Outcome Measures

ultrasound patency, clinical patency, target vessel and target lesion revascularization, cardiovascular events, quality of life at 3, 6 and 12 months after the procedure

Full Information

NCT ID

NCT00715416

First Posted

July 11, 2008

Last Updated

July 11, 2008

Sponsor

Vienna General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00715416

Brief Title

PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents

Official Title

Balloon Angioplasty vs. Primary Stenting of Femoropopliteal Arteries Using Self-Expandable Nitinol Stents - a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2006

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Vienna General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators evaluated whether primary implantation of a self-expanding nitinol stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Vascular Diseases, Intermittent Claudication, Angioplasty

Keywords

peripheral vascular diseases, Intermittent Claudication, Angioplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

primary nitinol stent placement of superficial femoral artery lesions

Arm Title

Arm Type

Active Comparator

Arm Description

balloon angioplasty of superficial artery lesions with secondary stent placement in case of >30% residual stenosis after the procedure

Intervention Type

Device

Intervention Name(s)

Nitinol stent

Intervention Description

Interventions are performed percutaneously from either an antegrade or an over-the-bifurcation approach. After insertion of an 6 French sheath, 5000 IU of heparin are administered intra-arterially. After passage of the stenosis/occlusion with the guide wire, patients are randomized to either PTA or primary stent implantation. For standardized documentation of the lesion morphology and comparability during follow-up, a ruler is fixed at the patients thigh with the distal end exactly overlapping at the upper edge of the patella. As a bail-out procedure in the PTA group, stent placement is performed in cases with a residual stenosis of more than 30% in the worst view angiogram.

Intervention Type

Procedure

Intervention Name(s)

Nitinol Stent Placement

Other Intervention Name(s)

Product: peripheral stent system, Type: ASTRON, EC class: IIb, Certificate number: G1 01 10 10275 193, EC number: 0123, Date of issue: 26.10.2001

Intervention Description

Balloon angioplasty compared to primary stent implantation for long segment superficial femoral artery lesions

Primary Outcome Measure Information:

Title

occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis).

Time Frame

3, 6, 12 months

Secondary Outcome Measure Information:

Title

ultrasound patency, clinical patency, target vessel and target lesion revascularization, cardiovascular events, quality of life at 3, 6 and 12 months after the procedure

Time Frame

3, 6, 12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: symptomatic peripheral artery disease with severe intermittent claudication (Fontaine stage IIb) critical limb ischemia in patients with stenosis or occlusions originating in the SFA up to 25 cm length of stenosis/occlusion Exclusion Criteria: previous bypass surgery at the site of treatment history of intolerance of anti-platelet therapy adverse reaction to heparin bleeding diathesis creatinine >2.5 mg/dL active bacterial infection allergy to contrast media previous stent placement at or immediately adjacent to the target lesion

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Schilliger, Prof

Organizational Affiliation

General Hospital of Vienna, Department of Angiology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Martin Schillinger, Prof

Organizational Affiliation

General Hospital of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

16672699

Citation

Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.

Results Reference

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PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents

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